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Preparation of amniotic membrane (AM) by air drying method followed by radiation sterili- zation is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation steriliza- tion dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM prep- aration could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10 -1 , and sample item portion = 1, was carried out using Method VDmax of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products—radiation—part 2: establishing the sterilization dose, Method VDmax—substantia- tion of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differ- ences in the bioburdens of the four batches (a = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid steriliza- tion dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor's type of delivery, normal or caesarean, showed no signif- icant effect on the levels of microbial counts on the tested AMs (a = 1 %).

The continued evidence of the presence and spread of pathogenic organisms on environmental surfaces in acute, ambulatory, short-term and long-term healthcare facilities and in the home, suggests that additional cleaning and maintenance protocols are needed. The gold standards of “good hand washing” and daily disinfecting of critical surfaces do not appear to be able to combat the increasing rate of hospital-acquired infections.